The Opportunity Reporting to the Director of Quality Assurance, this GMP Professional will manage ImmunoGen\u2019s internal & external auditing programs and be the process owner of the Quality Risk Management (QRM) program. Support Supply Relationship Manager in the qualification of Contract Manufacturing Organizations (CMOs) and Contract Testing Labs (CTLs). Plan and perform audits according to the requirements specified in ImmunoGen SOPs. Develop a contractor auditor program to support execution of audits during peak volume periods. Develop budget for contractor program and track adherence to budget. Ensure PAI readiness of CMOs and CTLs. Perform PAI readiness risk assessment and oversee mock PAIs as needed. Prepare audit reports according to ImmunoGen requirements and timelines and Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures. Ensure adequate definition and documentation of mitigation plan when applicable. Manage the Vendor Notification program assessing and documenting change notifications from CMOs\/CTLs in cooperation with SMEs. Act as the GMP Risk Management process owner responsible for continued maintenance, improvement and integration of Quality Risk Management into relevant elements of ImmunoGen\u2019s quality system. Manage the Risk Register and provide leadership, training and facilitation for risk management efforts across the organization. Track progress-to-plan for implementation of risk mitigations that result from risk assessments (i.e. due date, tasks, owners, etc.) Compile quality metrics related to audits and risk management for dissemination at Quality Management Review meetings. Monitor industry inspection trends, new\/revised regulations and guidance for impact to operations. Recommend and implement improvements to the audit and risk management programs based on new regulations, guidance documents, and industry. Revise\/author QRM Standard and SOPs as needed. Support development\/training of external manufacturing team members in the area of audits. Support Health Authorities commitments and global commitments\/initiatives as an outcome of inspection findings. Who You Are Bachelor\u2019s degree in Chemistry, Pharmacy, Microbiology, Engineering or another related science Must have 10 years of experience as a lead auditor with GMP manufacturers and laboratories Experience with PAIsand ensuring PAI readiness Experience with identification and oversight of contract auditors Experience managing\/ running an audit program Certified Quality Auditor (ASQ or other)\u00a0 Experience with application of Risk Management tools and methodologies such as: FMEA, PHA, Risk Rank and Filtering, etc. Solid understanding of ISO standards, FDA and EMA GMP requirements, and other applicable regulatory guidelines Ability to travel, on average, 20-30% Results Oriented: Establishes clear goals and expectations and effectively allocates resources. Consistently delivers. Has flexible and creative problem solving skills.\u00a0 Strategic Thinker: Is able to see the big picture and understand the challenging and sometimes conflicting needs within an organization. Thinks logically, develops and evaluates options, and identifies pros and cons. Constantly strives for ways to add value and improve how work is done.\u00a0 Team Leader: Able to manage and lead a group of diverse individuals and assess and nurture talent. Encourages team to present and debate their best ideas and holds the team accountable for results. \u00a0Strong, clear communicator who recognizes that new ideas and approaches require a great deal of communication. Able to communicate across functions and bring people together around a common goal.\u00a0 \u00a0Able to work effectively with limited direction in a complex, fast paced environment. \u00a0Positive Energy: Brings energy into the room and is a strong collaborator. \u00a0Drives and supports new ways of thinking and embraces change. Patient Focus : Work with urgency, and go the extra mile. The patient is waiting. ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity\/expression, national origin\/ancestry, age, disability, marital and veteran status.
Website : http://www.immunogen.com/